Associate Director Quality Assurance (FvP)

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) a serious liver disease that can progress to cirrhosis liver failure need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose : leading the fight against MASH.

Madrigals medication Rezdiffra (resmetirom) is a once-daily oral liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

Our success is driven by our people. We are building a dynamic inclusive and high-performing culture that values scientific excellence operational rigor and collaboration. To support our continued growth we are strengthening our workforce strategy to ensure we have the right talent at the right time in the right way.

Position Summary

We are seeking an experienced and Swissmedic -recognized Fachtechnisch verantwortliche Person ( FvP )to support the establishment of alocal pharmaceutical quality systemin Switzerland and lead the companys efforts to obtain and maintain aPharmaceutical Establishment License (PEL). This role is critical in ensuring compliance withSwiss and EU GMP / GDPrequirements and in enabling local operations such as importation release distribution and oversight of pharmaceutical products.

Key Responsibilities

Quality System Establishment :

Design implement and maintain afit-for-purpose Quality Management System (QMS)aligned with Swissmedic EU GDP / GMP and company globalQuality and Compliance processes and standards

Draft review and approve SOPs policies and related quality documentation

Define quality metrics and processes for internal audits deviations CAPA change control and management review

PEL Application & Maintenance :

Lead the preparation submission and defense of thePEL application to Swissmedic

Serve as the primary contact point for Swissmedic during inspections and communications

Ensure continuous compliance with license conditions and support renewals and variations as needed

Ensure authorised operations are conducted in compliance with the conditions of Swissmedic Establishment License for import incl. release to the market wholesale export and trade in foreign countries as well as with the License for Controlled Substances and to Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013 / C 343 / 01)

Batch Release & Oversight :

Review manufacturing and quality records

Certify batch release for the Swiss Market or Export

Ensuring compliance with GMP and Swiss legal requirements (if applicable)

GMP and GDP Compliance :

Qualify / Audit and Manage third-party service providers (e.g. CMO logistics warehousing)

Oversee GDP-compliant distribution of medicinal products in Switzerland

Ensure temperature monitoring excursion handling and product integrity throughout the supply chain

Ensure temperature monitoring excursion handling and product integrity throughout the supply chain

Inspection Readiness :

Prepareand lead Quality activities forthe site for Swissmedic and / or EU inspections and audits

Coordinate and respond to inspection findings and ensure implementation of corrective actions

Stakeholder Collaboration :

Liaise with internal departments (Regulatory Affairs Supply Chain Clinical) and external partners (contract manufacturers distributors)

Provide regulatory guidance for local and EU pharmaceutical operations

Key contributor to the Global Quality management Review

Profile

Experience in setting up pharmaceutical operations or start-up environments

Excellent organizational communication and problem-solving skills

Ability to work independently and manage multiple priorities

Strong cross-functional collaboration and ability to work effectively with IT Business Owners QA and external vendors

Skilled in managing relationships across global teams (US EU Switzerland)

Strong written and verbal communication skills forpresenting to executive stakeholders

Excellent troubleshooting skills to address complex quality issues

Aptitude for identifying inefficiencies and driving process improvements within QA frameworks

Meticulous review of documentation to ensure regulatory and quality robustness

Ability to mentor others in quality and best practices

Initiative in shaping compliance culture across the organization

Qualifications

Swiss-recognized Qualified Person (QP) and / or Responsible Person (RP) per TPA and Swissmedic requirements

Degree in Pharmacy Chemistry Biology or related field

Minimum of8-10 years of experience in Quality Assurance within the pharmaceutical biotechnology or medical device industrieswith at least5 years of experience in a Fachtechnisch verantwortliche Person ( FvP )role within the pharmaceutical industry

Proven experience with Swissmedic regulations PEL submissions and GMP / GDP audits

Strong knowledge of Swiss and EU pharmaceutical legislation

Mentor cross-functional teams in Quality best practices while influencing executive decision-making through clear data-driven communication and quality-driven leadership

Enthusiastic highly motivated and a growth mindset

Positive attitude and flexible approach to work

Fluency in EnglishandGerman

All full-time employees receive equity which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance we empower employees to think like owners giving them a stake in the organization.

Full-time employees are also eligible for comprehensive benefits including flexible paid time off medical dental vision and life / disability insurance and 401(k) offerings (i.e. traditional Roth and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance legal services and other addition we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal state and local laws.

We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance please contact

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications merit and business need. Applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin age disability protected veteran or disabled status or other characteristic protected by applicable federal state or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site.

Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals Hiring Managers seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigals name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g. fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.

Please also note that any correspondence with regard to employment would come from an authorized email address or from an email address from one of our trusted search firm partners. We are aware that incorrect / fraudulent email addresses with Madrigal misspelled have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal we recommend that you : do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to .

Required Experience :

Director

Key Skills

Quality Assurance,FDA Regulations,ISO 9001,Root cause Analysis,Biotechnology,Clinical Trials,Quality Systems,Food Processing,Quality Control,Quality Management,cGMP,HACCP

Employment Type : Full-Time

Experience : years

Vacancy : 1